A Real World Study on the Efficacy and Safety of Lacosamide as Add-on Therapy for Focal-onset Epilepsy

NCT ID: NCT04737837

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-02-28

Brief Summary

The purpose of this trial is to evaluate the efficacy, safety, and pharmaco-economics of Lacosamide Tablet as first add-on therapy for uncontrolled focal onset epilepsy ,invetigating effects of lacosamide Tablet on cognitive function of children and anxiety and depression of adults with focal onset seizures In real-world clinical setting

Detailed Description

In many real world, lacosamide as the first add-on therapy can significantly improve the seizure freedom rate. Moreover, many pharmacoeconomic studies in Sweden and the United States have confirmed that lacosamide is a more cost-effective option.This is a real-world study to evaluate the efficacy, safety and cost-effectiveness of Generic lacoxamide tablets in the treatment of patients with focal epilepsy. During the trial, patients with focal epilepsy were treated with lacosamide for the first time after the failure of the original antiepileptic drug. At the same time, the cost-effectiveness of Generic lacosamide was evaluated from the perspective of economics, in order to provide the basis for the clinical choice for Chinese epilepsy patients.

Conditions

Epilepsy; Focal-Onset Seizure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

children

Children aged 4\~16 years with focal onset seizures

lacosamide

Intervention Type: DRUG

lacosamide as first add on therapy

Adult

Adults aged \>16 years with focal onset seizures

lacosamide

Intervention Type: DRUG

lacosamide as first add on therapy

Interventions

lacosamide

lacosamide as first add on therapy

Intervention Type: DRUG

Other Intervention Names

Xinkang

Eligibility Criteria

Inclusion Criteria

• Before the start of the trial, to obtain the informed consent approved by the ethics committee voluntarily signed by each subject. For underage subjects, the informed consent jointly signed by the subjects themselves (≥10 years ) and their parents or legal guardian (in which the underage needs the signature with their parents or legal guardian, and the underage is defined as the subject under 18 years of age) ;
• Male and female, between the ages of 4 and 75 years;
• Diagnostic criteria of focal onset seizures (with or without focal to bilateral tonic clonic seizures) was based on the 2017 Classification of Epileptic Seizures from the International League Against Epilepsy (ILAE);
• In the 4 weeks before enrollment and during the baseline period, patients have been on only one stable dosage of antiepileptic drug and suitable for lacosamide add-on therapy according to their investigators criteria;
• During the 8-week retrospective baseline period, patients must have had at least 4 focal onset seizures per 28 days on average.

Exclusion Criteria

• Patients had received previous lacosamide treatment;
• Female patients are pregnant, breast-feeding, and will not use contraception during the trial;
• Patients had known allergies to lacosamide or any ingredients of the drug, or with allergic constitution;
• Patients have a history of status epilepticus in the last 12 months;
• History of chronic alcohol or drug abuse; 6.history of suicide attempt or suicidal ideation in the past 6 months;
• Current use of Antidepressants, anxiolytics or antipsychotics;
• Patients suffer from progressive diseases that affect the patient's brain and its function;
• Sychogenic nonepileptic seizures;
• Patients suffer from serious lung and blood system diseases, malignant tumor, lower immune function and psychosis;
• Patients wil receive ketogenic diet therapy, or Four weeks before entering the screening period, patients used other drugs that may affect the absorption, distribution, metabolism and excretion of lacosamide, such as antipsychotics, monoamine oxidase inhibitors, barbiturates (except for combined use as anticonvulsant therapy), narcotic analgesics.
• Patients Had epilepsy brain surgery, or will undergo epilepsy surgery in the next four months.
• Investigators considered Patients as unsuitable for this trial.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dong Zhou, Doctor

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

Beijing Children's Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Shenzhen Children's Hospital

Shenzhen, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Wuhan Union Hospital

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing Brain Hospital

Nanjing, Jiangshu, China

The Children's Hospital Affiliated to Suzhou University

Suzhou, Jiangshu, China

Wuhan Children's Hospital

Wuhan, JiangShu, China

The First Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Provincial Hospital

Jinan, Shandong, China

Huashan hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

The Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Xi'an Jiaotong University College of Medicine

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

West China Second Hospital of Sichuan University

Chengdu, Sichuan, China

Children's Hospital Affiliated to Medical College of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Ruipeng Zhang, MA

Role: CONTACT

zhangruipeng@qfyy.com.cn

13654951067

Facility Contacts

Fang Fang

Role: primary

Qin bing, Doctor

Role: primary

Weiping Liao, Doctor

Role: primary

Liao Jianxiang

Role: primary

Xuejun Deng

Role: primary

Peng Jing

Role: primary

Rui Zhang

Role: primary

Tang Jihong

Role: primary

Sun Dan

Role: primary

Zhao Chuansheng

Role: primary

Gao yuxing

Role: primary

Zhou Shuizhen

Role: primary

Shaoping Huang

Role: primary

Wu Xintong, Doctor

Role: primary

36853839@qq.com

13882269092

Gao feng

Role: primary

Other Identifiers

QF-LCM2020-1

Identifier Type: -

Identifier Source: org_study_id